UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001301
Receipt No. R000001536
Scientific Title A prospective,randomized,single-blind,comparative study of Inslow,palatinose-based liquid formula and Meibalance,standard balanced liquid formula,using viscera fat accumulation as a primary endpoint in adults patients with confirmed diagnosis of obesity and impaired glucose tolerance.
Date of disclosure of the study information 2009/01/01
Last modified on 2010/08/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A prospective,randomized,single-blind,comparative study of Inslow,palatinose-based liquid formula and
Meibalance,standard balanced liquid formula,using viscera fat accumulation as
a primary endpoint in adults patients with
confirmed diagnosis of obesity and impaired glucose tolerance.
Acronym A prospective,randomized,single-blind,comparative study of Inslow,palatinose-based liquid formula and Meibalance,standard balanced liquid formula ingested for a certain period,using visceral fat accumulation as a primary endpoint in adults patients with obesity
and impaired glucose tolerance.
Scientific Title A prospective,randomized,single-blind,comparative study of Inslow,palatinose-based liquid formula and
Meibalance,standard balanced liquid formula,using viscera fat accumulation as
a primary endpoint in adults patients with
confirmed diagnosis of obesity and impaired glucose tolerance.
Scientific Title:Acronym A prospective,randomized,single-blind,comparative study of Inslow,palatinose-based liquid formula and Meibalance,standard balanced liquid formula ingested for a certain period,using visceral fat accumulation as a primary endpoint in adults patients with obesity
and impaired glucose tolerance.
Region
Japan

Condition
Condition Obesity and impaired glucose tolerance
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare mitigation effect of Inslow
(palatinose-based liquid formula)and Meibalance(standard balanced liquid formula)on risk factors of metabolic syndrome in adults patients with obesity
and impaired glucose tolerance. The primary endpoint of efficacy for the study
is visceral fat accumulation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Visceral fat accumulation
Key secondary outcomes Hemoglobin A1c
HOMA index
Area under the curb of glucose concentration after 75gOGTT
Area under the curb of insurin
concentration after 75gOGTT

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Inslow(palatinose-based liquid formula)
ingested group
1.Period of intervention:
a)nutritional consultation period;
3 months
b)period of ingestion;6 months
2.Intake amount per day:200 Kcal
3.Intake frequency per day:once a day
Interventions/Control_2 Meibalance(standard balanced liquid formula) ingested group
1.Period of intervention:
a)nutritional consultation period;
3 months
b)period of ingestion;6 months
2.Intake amount per day:200 Kcal
3.Intake frequency per day:once a day
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1)Inclusion criteria at the preliminary
registration
1.BMI>=25Kg/m2
2.Fasting glucose concentrations:
100-125mg/dL
3.HbA1c 5.2%-6.5%
4.Volunteers with written informed consent
2)Inclusion criteria at the registration
1.BMI>=25kg/m2
2.Fasting glucose concentrations:
100-125mg/dL
3.HbA1c 5.2%-6.5%
4.Successful volunteers in the nutritional
period
Key exclusion criteria 1.Participants recieveing anti-diabetic
drug
2.Deep chronic drinker
3.Participants with following
complications or with past histry
*Exocrine diseases of pancreas:
Pancreatitis;Tumor;
Hemochromatosis,etc.
*Endocrine diseases:
Cushings's syndrome;Acromegaly,
Pheochromocytoma;
Hyperthyroidism,etc.
*Hepatic diseases:Chronic hepatitis,
Hepatic cirrhosis
*Patients with gastrectmy or with chronic
gastro-enteral disease
4.Female who is pregnant, in a lactation
period, child-bearing potential or
wishing to be pregnant.
5.Participants judged to be inadequate by
the investigator.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Takeda
Organization University of Tokushima Graduate School
Division name Department of Clinical Nutrition
Zip code
Address 3-8-5Kuramoto-cho,Tokushima
TEL 088-633-7093
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiromitsu Aonuma
Organization Meiji Dairies Corporation Food Science Institute
Division name Nutrition Research Department Clinical Study and Scientific Assessment Section
Zip code
Address 540 Naruda, Odawara, Kanagawa
TEL 0465-37-3617
Homepage URL
Email HIROMITSU_AONUMA@MEIJI-MILK.COM

Sponsor
Institute Meiji Dairies Corporation
Institute
Department

Funding Source
Organization Meiji Dairies Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Internal Medicine of Tokushima University
Hospital of Medicine and Dentistry
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 1)長崎大学医学部・歯学部附属病院(長崎県) 1)Nagasaki University Hospital
2)徳島大学病院               2)Tokushima University Hospital
3)滋賀医科大学病院             3)Shiga Medical University Hospital
4)京都大学病院               4)kyoto University Hospital
5)松原メイフラワー病院              5)Matsubara Mayflower Hospital

Other administrative information
Date of disclosure of the study information
2009 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
2010 Year 11 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 08 Month 06 Day
Last modified on
2010 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001536

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.